Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in FTU

Hearing Impairment Clinical Trial

— I-ACE  

Official title:

Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in First Time Hearing Aid Users: A Randomised Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05815667
• Other study ID #: IAK RCT
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: May 2023

Study information

• Verified date: April 2023
• Source: Horselvarden Region Ostergotland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hearing impairment affects the ability to communicate, which can adversely affect both mental and physical health. The most common used rehabilitation method in hearing impairment is hearing aid fitting. Even with optimally fitted hearing aids, many struggle to hear in situations with difficult listening conditions. Active Communication Education (ACE) is an interactive group rehabilitation programme aiming to help those with hearing loss communicate more effectively using communication strategies to cope better in everyday life. An Individualised Active Communication Education (I-ACE) distributed digitally could enable those unable to get to the hearing care facility, or don't want to join the group sessions to benefit from the programme. This project aims to investigate the effects of the swedish digital version of the I-ACE in first time hearing aid users.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adults >20 years old who have been fitted with hearing aids for the first time (first time users) 6 - 12 months prior.
• Computer experience and access to computer, tablet and/or smartphone with internet access.
• Access to BankID or equivalent.

Exclusion Criteria:

• Those who have participated in Active Communication Education prior.

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

Behavioral:
• Individualised Active Communication Education (I-ACE)
The swedish I-ACE consists of five modules with different themes, all with sections of information alternated with reflective tasks. The participants are assigned one module each week and provided with weekly feedback from a health care professional on their work, before being assigned the next module.

Locations

Country	Name	City	State
Sweden	Hörselvården Region Östergötland	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Horselvarden Region Ostergotland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Communication and Acceptance Scale (CAS)	Assessing changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss.; Minimum 18 points to maximum 90. Higher score indicates a lower impact of the hearing loss.	Baseline, directly post intervention and 6 months post intervention.
Primary	Communication Strategies Scale (CSS)	Assessing changes in use of verbal, non-verbal and maladaptive communication strategies.; Minimum 25 points to maximum 100. Higher score indicates a greater use of communication strategies.	Baseline, directly post intervention and 6 months post intervention.
Primary	The Hearing Handicap Inventory for the Elderly (HHIE)	Assessing changes in emotional and social effects of hearing loss. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.	Baseline, directly post intervention and 6 months post intervention.
Secondary	The International Outcome Inventory for Alternative Interventions (IOI-AI)	Assessing changes in perceived effectiveness with an alternative intervention, in this case the I-ACE.; Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.	Directly post intervention and 6 months post intervention.
Secondary	The International Outcome Inventory for Hearing Aids (IOI-HA)	Assessing changes in perceived effectiveness and satisfaction with hearing aids.; Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.	Baseline, directly post intervention and 6 months post intervention.